Cost of FDA Registration
Cost of FDA registration varies with type of products and FDA classification, there are two types of cost involved in FDA registration process. FDA fees and consultant or US FDA Agent fees; if you want to list a product which require FDA clearance or approval (e.g., medical device comes under 510k or PMA classification or a drug comes under marketing category NDA or ANDA) you need to add the cost of FDA review or approval program also.
There are no FDA fees for a food facility, but all foreign facilities must have a US FDA Agent, usually the agent will be a third party and the facility need to pay for their service. LMG fees for US FDA Agent service is $349/year, which includes a free certificate of FDA registration.
FDA Registration fees incurred in medical device registration, FDA fees for the year 2021 is $5546, FDA fees will vary each year. LMG fees for US FDA Agent service for a medical device establishment is $449/Year and listing fees is $50/device. Please visit the FDA Fees page to see the device clearance or approval fees.
There is a proposed fee for OTC Monograph drug manufacturing facility registration, but it is not yet published, there is no FDA fees for other types of drug establishment registration. LMG fees for drug establishment registration and us agent service is $649/year; Our fee for drug listing is $399/listing. If your drug comes under marketing category NDA or ANDA there are FDA review fees.
FDA registration for cosmetic establishment is voluntary and is free, the total cost only involved is the consultant fees (if you get help from a consultant). LMG fees for cosmetic FDA registration assistance is $449/establishment.
Dietary supplement comes under food regulations, the fees is same as food facility. LMG fees for dietary supplement facility registration and FDA agent service is $349/year.
FDA does not issue a registration certificate, but as your US Agent, LMG will issue a registration certificate after successfully completing FDA registration. You can use this certificate as proof of FDA registration to your customers and industry.